Recordati files for Japan approval of Isturisa
Italian drugmaker Recordati (RECI: MI) today announced the submission of the Japanese New Drug Application (JNDA) to the Ministry of Health, Labor and Welfare (MHLW) seeking marketing approval for osilodrostat, an oral inhibitor of 11-beta-hydroxylase for the treatment of patients with Cushing’s syndrome (CS).
The JNDA for osilodrostat is primarily based on data generated by the clinical program which included Japanese patients.
In the Phase III LINC-3 study, a significantly higher proportion of patients treated with Isturisa maintained normal mean urinary free cortisol (mUFC) at the end of the eight-week randomized withdrawal period (week 34) versus placebo (86.1% vs 29.4%). The safety profile was manageable.
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